Medical valve

ABSTRACT

A medical valve includes: (a) a housing having a hollow body opened at the top end, wherein the tip of a male luer is to be removably inserted in the housing; (b) a spike disposed to extend longitudinally in the housing, the spike except at least the top end portion being formed in an approximately tapered shape in which its outside diameter becomes progressively smaller toward the top end portion, wherein a fluid transferring passage, which is opened radially outwardly, is formed to extend longitudinally in the spike; and (c) an elastic seal having an elastically deformable tubular shape fitted on the spike to seal the spike, the elastic seal including a top end portion having an openable/closable portion to be openably closed over the spike, wherein the elastic seal is elastically deformed to be downwardly shrunk by downward pressure due to the tip of the male luer.

This application is a division of U.S. patent application Ser. No.10/800,913 filed Mar. 16, 2004, which claims priority of Japanese PatentApplication No. 2003-071260, filed Mar. 17, 2003, which is incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates to a medical valve which makes it possibleto perform supply of a fluid and the like through the connection of amale luer without using a metal needle because of the problem oferroneous needle sticking and the like by an operator, in a mixing plugwhich is provided in a fluid circuit, for example, a fluid infusion bag,an intermediate portion of a fluid infusion line (route) or an externalfluid circuit, for the purposes of effecting supply, mixing, additionaladministration of medicament solutions such as trace elements, vitaminsand antibiotics.

DESCRIPTION OF THE RELATED ART

As a medical valve in which a male luer such as a syringe or other fluidcircuit is connected to a fluid infusion route without using a metalneedle, there is a medical valve in which a spike contained in a housingis covered with an elastic seal (refer to, for example, JP-T-7-505064,EP 0681493B1, U.S. Pat. No. 6,029,946).

In this construction, by the application of pressure by a tip of a maleluer, the elastic seal is compressed downwardly and the spike isinserted through the elastic seal and is exposed upwardly to enter thetip of the male luer. In this manner, the inside of the male luer and afluid transferring passage inside the spike communicate with each othervia an opening of a side surface of the spike, whereby a fluid can betransferred. In addition, when the application of pressure to theelastic seal by the tip of the male luer is cancelled, the elastic sealis expanded from its compressed state by its resilient force and isrestored to the original size, whereby the spike is sealed in theelastic seal.

The spike is generally made of a resin in terms of cost. However, in theabove-mentioned related art, the fluid transferring passage is formed inthe inside of the spike and is completely covered with the peripheralwall portion of the spike, so that if the outside diameter of the spikeis made small, there is a need for making the peripheral wall portion ofthe spike extremely thin, and in this case, it is extremely difficult toform the spike from a resin.

For this reason, it is more preferable that the inside diameter of thetip of the male luer which the spike enters becomes larger (for example,the inside diameter is 1.5 mm or more). However, if the male luer is asyringe made of glass and the tip is made of glass, it is difficult toenlarge the inside diameter of the tip in terms of the problem ofmolding, and in this case, there is the problem that the spike cannot bemade to enter the tip and that the male luer and the medical valvecannot be connected to each other.

BRIEF SUMMARY OF THE INVENTION

As a result of earnest investigations made by the inventors to solve theproblems associated with the conventional techniques, the invention hasbeen completed.

An object of the invention is to provide a medical valve to which a maleluer can be easily connected even if the inside diameter of the tip ofthe male luer is small.

The above-mentioned object and other objects of the present inventionwill be clarified further more in the following description, and theseobjects are attained by the present invention comprising theconstitution mentioned below.

The invention relates to a medical valve to which a male luer is to beseparably connected comprising:

(a) a housing having a hollow body opened at the top end, wherein thetip of the male luer is to be removably inserted in the housing;

(b) a spike disposed to extend longitudinally in the housing, the spikeexcept at least the top end portion being formed in an approximatelytapered shape in which its outside diameter becomes progressivelysmaller toward the top end portion, wherein a fluid transferringpassage, which is opened radially outwardly, is formed to extendlongitudinally in the spike, the bottom portion of the fluidtransferring passage being connected to a fluid circuit; and

(c) an elastic seal having an elastically deformable tubular shapefitted on the spike to seal the spike, the elastic seal comprising a topend portion having an openable/closable portion to be openably closedover the spike, wherein the elastic seal is elastically deformed to bedownwardly shrunk by downward pressure due to the tip of the male luer,thereby the openable/closable portion is brought into abutment with thespike, and is elastically deformed to be opened radially outwardly to befitted onto the spike, so that the inside of the male luer communicateswith the fluid transferring passage of the spike.

The medical valve to which a male luer is to be separably connected maycomprise:

(a) a housing having a hollow body opened at the top end, wherein thetip of the male luer is to be removably inserted in the housing;

(b) a solid spike disposed to extend longitudinally in the housing, thespike except at least the top end portion being formed in an shapeapproximately tapered upwardly, wherein a groove-shaped fluidtransferring passage, which is opened radially outwardly, is formed toextend longitudinally in the peripheral surface of the spike, the bottomportion of the fluid transferring passage being connected to a fluidcircuit; and

(c) an elastic seal having an elastically deformable tubular shapefitted on the spike to seal the spike, the elastic seal comprising a topend portion having an openable/closable portion to be openably closedover the spike, wherein the elastic seal is elastically deformed to bedownwardly shrunk by downward pressure due to the tip of the male luer,thereby the openable/closable portion is brought into abutment with thespike, and is elastically deformed to be opened radially outwardly to befitted onto the spike, so that the inside of the male luer communicateswith the fluid transferring passage of the spike.

The spike described below may be used instead of the spike describedabove.

For example, the spike may comprise:

(i) a joining portion constituting the top end portion of the spike; and

(ii) a plurality of branch portions, which constitutes the remainingportion of the spike, formed integrally with the joining portion tobranch off downwardly from the joining portion,

and wherein the fluid transferring passage is defined between the branchportions.

The spike may comprise a plurality of divided bodies extending along theentire longitudinal length thereof,

and wherein the fluid transferring passage is defined between thedivided portions.

The spike may comprise:

(i) a plurality of main portions extending along the entire longitudinallength of the spike; and

(ii) a bridge portion formed integrally with the main portions anddisposed between the main portions to join the main portions together,

wherein the fluid transferring passage is defined between the mainportions.

The medical valve, to which a male luer is to be separably connected,may comprise:

(a) a housing having a hollow body opened at the top end, wherein thetip of the male luer is to be removably inserted in the housing;

(b) a spike disposed to extend longitudinally in the housing, the topend portion of the spike having an approximately cylindrical shape, thetop end surface of the spike being an approximately hemisphericalsurface which is upwardly convex, the spike except the top end portionbeing formed in an approximately tapered shape in which the outsidediameter becomes progressively smaller toward the top end, wherein afluid transferring passage, which is opened radially outwardly, isformed to extend longitudinally in the peripheral surface of the spike,the bottom portion of the fluid transferring passage being connected toa fluid circuit;

(c) an elastic seal having an elastically deformable tubular shapefitted on the spike to seal the spike, the elastic seal comprising a topend portion having an openable/closable portion to be openably closedover the spike, wherein the elastic seal is elastically deformed to bedownwardly shrunk by downward pressure due to the tip of the male luer,thereby the openable/closable portion is brought into abutment with thespike, and is elastically deformed to be opened radially outwardly to befitted onto the spike, so that the inside of the male luer communicateswith the fluid transferring passage of the spike.

The spike may comprise at least three fins projecting radially outwardlyfrom the axial portion, and wherein the fluid transferring passages aredefined between adjacent ones of the fins.

The fins may be circumferentially spaced from one another at equalintervals, the edge of each of the fins being placed in abutment withthe inside surface of the elastic seal.

A portion of the elastic seal, which is brought in abutment with thefins, may have a cross section of an approximately polygonal shape.

The bottom portion of the spike may be inserted in and fixed to thehousing.

The central portion of the bottom surface of the openable/closableportion may be made approximately flat and be opposed to the top end ofthe spike across a gap.

A ring-shaped projection, which projects radially inwardly and is placedin abutment with the top end portion of the spike, may be formed toextend around approximately the entire circumference of the insidesurface of the top portion of the elastic seal.

The elastic seal except the openable/closable portion and the bottom endportion may have a bellows-shaped shrinkable portion.

The top end surface of the housing and the top end surface of theelastic seal may be made substantially flush with each other.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 to 5 show a first embodiment of the invention, and FIG. 1 is across-sectional view.

FIG. 2 is a cross-sectional view taken along line A-A of FIG. 1.

FIG. 3 is a perspective view of the spike of FIG. 1.

FIG. 4 is a view of the operating state of FIG. 1.

FIG. 5 is a view of the operating state of FIG. 4.

FIG. 6 is a perspective view showing a second embodiment of theinvention.

FIG. 7 is a perspective view showing a third embodiment of theinvention.

FIG. 8 is a perspective view showing a fourth embodiment of theinvention.

FIGS. 9 to 11 show a fifth embodiment of the invention, and FIG. 9 is aperspective view.

FIG. 10 is a cross-sectional view taken along line B-B of FIG. 9.

FIG. 11 is a cross-sectional view taken along line C-C of FIG. 10.

FIGS. 12 to 17 show a sixth embodiment of the invention, and FIG. 12 isa cross-sectional view.

FIG. 13 is a partly enlarged view of FIG. 12.

FIG. 14 is a cross-sectional view taken along line D-D of FIG. 12.

FIG. 15 is a perspective view of the spike of FIG. 12.

FIG. 16 is a view of the operating state of FIG. 12.

FIG. 17 is a view of a modification of the invention shown in FIG. 14.

DETAILED DESCRIPTION OF THE INVENTION

A first embodiment in which the invention is applied to a mixing plugwill be described below with reference to FIGS. 1 to 5. FIGS. 1, 4 and 5show a mixing plug, and the mixing plug has a housing 1, a spike (slitrod) 2, and an elastic seal (member) 3.

As also shown in FIG. 2, the housing 1 has a hollow shape opened at bothtop and bottom ends so that a male luer is removably inserted into thehousing 1, and has a body 7 and a connector 8. Polycarbonate resins,acrylic resins, hard vinyl chloride resins, high-density polyethyleneresins, polypropylene resins, acrylonitrile-butadiene-styrene blockcopolymer resins, polyamide resins, polyethylene telephthalate resins,polybuthylene telephthalate resins, polyacetal resins, fluororesins,polyphenylene sulfide resins, polyethersulfone resins, polyether etherketone resins, liquid crystal polymeric resins and the like can beenumerated as the constituent materials of the body 7 and the connector8. It is also possible to use reinforced materials prepared bycompounding the above-noted resins with glass fibers, graphites,inorganic fillers, carbon nanotubes or the like. Furthermore, to improvethe sterility of an upstream-side connecting portion 10 which will bedescribed later, an antimicrobial agent (such as silver- orzinc-substituted zeorite or silver-supported calcium phosphate) may alsobe kneaded with the constituent material of the body 7 and the like.

The body 7 is made hollow at both top and bottom ends, and a top portionof the body 7 is made an upstream-side (male) connecting portion ((male)coupling means or (male) coupling portion) 10 to which a male luer is tobe separably connected, and a male screw portion 11 is formed on theperipheral surface of the top portion. On the inside of the body 7, asmall-diameter hole 12 which is made the inside surface of theupstream-side connecting portion 10, a large-diameter hole 13 which ismade larger in diameter than the small-diameter hole 12, an engagementhole 17 which is made larger in diameter than the large-diameter hole13, and a female screw portion 14 which is made equal in diameter to theengagement hole 17 and in which a female screw is formed are integrallyformed to be arranged in named order in the downward direction. Anabutment surface 16 which is formed in a stepped shape and has a surfaceformed to face down is formed at the boundary portion between thelarge-diameter hole 13 and the engagement hole 17.

The connector 8 has a hollow shape opened at both top and bottom ends,and is inserted and fixed in the bottom portion of the body 7. Theconnector 8 has a mating portion 19 and a downstream-side (male)connecting portion ((male) coupling means or (male) coupling portion) 20which are integrally formed to be arranged in named order in thedownward direction. The mating portion 19 has a male screw formed aroundits peripheral surface, and the downstream-side connecting portion 20 ismade smaller in diameter than the mating portion 19. A communicationhole 22 is formed to extend through the inside central portion of theconnector 8 in the longitudinal direction.

The mating portion 19 is inserted and screwed into the female screwportion 14 of the body 7 and is fixed thereto. The downstream-sideconnecting portion 20 projects downwardly from the bottom end of thefemale screw portion 14 of the body 7 and is tapered in the downwarddirection, and a fluid transferring tube 26 shown by way of an exampleof a fluid circuit is separably connected to the downstream-sideconnecting portion 20. Incidentally, the fluid circuit includes not onlythe tubes of fluid infusion lines and external fluid circuits but alsovarious solution bags such as blood transfusion bags, and variousdevices. Incidentally, the connector 8 may be bonded to the body 7instead of being provided with the mating portion 19.

The spike 2 is disposed to extend in the inside of the body 7 in thelongitudinal direction from the bottom portion of the small-diameterhole 12 through the large-diameter hole 13 to the top end portion of thefemale screw portion 14, and is uprightly set on and adhesively fixed tothe mating portion 19 of the connector 8. As also shown in FIG. 3, thetop end portion of the spike 2 is made a straight portion 2A having anapproximately constant outside diameter, and the remaining portion ismade a tapered portion 2B which is formed in an (approximately) taperedshape so that its outside diameter becomes progressively smaller towardthe top end portion. Incidentally, the whole of the spike 2 may also beformed in an (approximately) tapered shape so that its outside diameterbecomes progressively smaller toward its top end. The maximum outsidediameter of the straight portion 2A is preferably approximately 0.5-2.0mm because, for example, the inside diameter of a tip of a glass syringeused as a male luer is 1.0-2.5 mm. As the constituent material of thespike 2, not only the same resins as the body 7 but also metal materialssuch as stainless steel can be enumerated.

The spike 2 has at least three (in this embodiment, four) fins 27 whichproject radially outwardly from its axial portion. The fins 27 arecircumferentially spaced from one another at equal intervals and extendthrough the entire longitudinal length of the spike 2, and longitudinalfluid transferring passages 28 are defined between adjacent ones of thefins 27. Each of the fluid transferring passages 28 is formed to extendthrough the entire longitudinal length of the spike 2, and is openedradially outwardly and is also opened at both top and bottom ends. Thebottom end opening of each of the fluid transferring passages 28communicates with the communication hole 22 of the connector 8.Incidentally, the fins 27 may also be disposed to extend over the entirelongitudinal length of the spike 2 except the straight portion 2A.

The elastic seal 3 has an elastically deformable tubular (approximatelycylindrical) shape, and is fitted onto the spike 2 from above to sealthe spike 2. The elastic seal 3 includes an openable/closable portion29, a shrinkable portion 30 and a flange portion 31 which are integrallyformed to be arranged in named order in the downward direction. Bydownward pressure due to the tip of the male luer, the elastic seal 3 iselastically deformed to be downwardly shrunk, thereby theopenable/closable portion 29 is brought into abutment with the spike 2,and is elastically deformed and opened radially outwardly to be fittedonto the spike 2, so that the tip of the male luer is allowed tocommunicate with the fluid transferring passages 28 of the spike 2.Natural rubber, synthetic polyisoprene rubber, butyl rubber, chloroprenerubber, silicone rubber, urethane rubber, styrene-butadiene rubber,ethylene propylene rubber, acrylic rubber, fluororubber, thermoplasticelastomers and the like can be enumerated as the constituent material ofthe elastic seal 3.

The openable/closable portion 29 constitutes the top end portion of theelastic seal 3 and has an approximately disk-like shape, and is disposedin the top portion of the small-diameter hole 12 of the body 7 and islocated over the spike 2 and has a top end surface (approximately) flushwith the top end surface of the body 7. The central portion of thebottom surface of the openable/closable portion 29 is made a concavesurface 32 which is made hemispherical in an upwardly concave shape, andthe concave surface 32 opposes the top end of the spike 2 across a gap.Incidentally, the concave surface 32 may also be placed in abutment withthe top end of the spike 2. The concave surface 32 may also be placed inabutment with the peripheral surface of the straight portion 2A of thespike 2. The outside diameter of the openable/closable portion 29 ismade (approximately) equal to or slightly smaller than the insidediameter of the small-diameter hole 11 of the body 7. A single (or twoorthogonal) radial slit 33 is formed to extend longitudinally throughthe openable/closable portion 29 except the peripheral portion thereof,and the slit 33 can be opened by radially outward elastic deformation ofthe openable/closable portion 29.

The shrinkable portion 30 constitutes the greater part of the elasticseal 3 and has a bellows-like form, and is extended downwardly from thebottom surface of the openable/closable portion 29 and contains thespike 2. It is to be noted that when the elastic seal 3 is presseddownwardly by the tip of the male luer, the elastic seal 3 shrinksdownwardly, and the greater part (or the whole) of this shrinkage isperformed by the shrinkable portion 30.

The flange portion 31 constitutes the bottom end portion of the elasticseal 3 and has a ring-like shape, and is formed to project radiallyoutwardly from the bottom end portion of the shrinkable portion 30. Theflange portion 31 is fitted in the engagement hole 17 of the body 7, andis clamped and fixed between the abutment surface 16 of the body 7 andthe mating portion 19 of the connector 8.

In the above-described embodiment, when fluid infusion, blood collectionor the like is to be performed by means of the mixing plug, after thetop end surface of the mixing plug has been sterilized, for example, atip 38 of a syringe 37 which is shown as one example of a male luer isinserted into the small-diameter hole 12 of the body 7 of the housing 1from the top end opening, as shown in FIGS. 4 and 5.

In this case, as shown by imaginary lines in FIG. 5, a syringe with alock member 40 having a female screw portion formed around its insidesurface is used as the syringe 37, and the syringe 37 can be positivelymaintained in the above-mentioned inserted state by screwing the femalescrew portion of the lock member 40 onto the male screw portion 11 ofthe body 7.

The elastic seal 3 is pressed by the above-mentioned insertion of thetip 38 of the syringe 37, and the shrinkable portion 30 and the like ofthe elastic seal 3 shrink against their resilient forces. During thistime, since the spike 2 except at least the top end portion is made thetapered portion 2B which is formed in an (approximately) tapered shapeso that the outside diameter becomes progressively smaller toward thetop end and the outside diameter increases not stepwise but continuouslyin the downward direction, the shrinkable portion 30 and the like of theelastic seal 3 smoothly shrink during the shrinkage of the elastic seal3 without being caught by a peripheral surface of the spike 2. Inaddition, since the elastic seal 3 except the openable/closable portion29 and the flange portion 31 is made the bellows-shaped shrinkableportion 30, the elastic seal 3 smoothly shrinks for this reason as well.

By the above-mentioned shrinkage and the abutment between the slit 33 ofthe openable/closable portion 29 of the elastic seal 3 and the top endof the spike 2, as shown in FIG. 5, the openable/closable portion 29 iselastically deformed radially outwardly to open the slit 33 of theopenable/closable portion 29, whereby the openable/closable portion 29is fitted onto the top end portion of the tapered portion 2B of thespike 2 to expose the straight portion 2A of the spike 2 and the top endportion of the fluid transferring passages 28. Accordingly, since theinside of the syringe 37 communicates with the tube 26 via the fluidtransferring passages 28 of the spike and the communication hole 22 ofthe connector 8, fluid infusion, blood collection or the like can beperformed similarly to the case of the related art.

When fluid infusion, blood collection or the like are completed, the tip38 of the syringe 37 is extracted from the body 7 of the housing 1.Accordingly, the shrinkable portion 30 and the like are expanded andrestored to the original size by the resilient forces of the shrinkableportion 30 and the like of the elastic seal 3. During this time, sincethe spike 2 except at least the top end portion is made the taperedportion 2B which is formed in an (approximately) tapered shape so thatthe outside diameter becomes progressively smaller toward the top end,the shrinkable portion 30 and the like of the elastic seal 3 smoothlyexpand without being caught by a peripheral surface of the spike 2 in amanner similar to the above-mentioned one. In addition, since theelastic seal 3 except the openable/closable portion 29 and the flangeportion 31 is made the bellows-shaped shrinkable portion 30, the elasticseal 3 smoothly expands for this reason as well. Furthermore, at thesame time as this expansion, the openable/closable portion 29 alsorises, and is restored to the original position. Accordingly, the slit33 of the openable/closable portion 29 is closed, and the spike 2 issealed by the elastic seal 3.

According to the above-mentioned embodiment, the fluid transferringpassages 28 which are opened radially outwardly are formed on the spike2, and even if, as in the case of the related art, the outside diameterof the spike 2 is made small in such a way that the fluid transferringpassages 28 are not completely covered with the peripheral wall portionof the spike 2, there is no need for making the peripheral wall portionof the spike 2 extremely thin, whereby even the spike 2 having a smalloutside diameter can be easily formed from a resin or the like.

Accordingly, even in the case where the male luer is the syringe 37 madeof glass and, the tip 38 is made of glass and is small in its insidediameter in the above-mentioned manner, the spike 2 can be easilyinserted into the tip 38, whereby the syringe 37 and the mixing plug canbe easily connected to each other.

FIG. 6 shows a second embodiment of the invention, and the fluidtransferring passage 28 which is made a groove having a V-likecross-sectional shape is formed to extend in the peripheral surface ofthe solid spike 2 along the entire longitudinal length thereof. Thefluid transferring passage 28 may be formed to extend along the entirelongitudinal length of the spike 2 except the straight portion 2A. Inaddition, in this embodiment as well as third to fifth embodiments to bedescribed later, as in the first embodiment as described above, theoutside diameter of the tapered portion 2B is made progressively smallertoward the top end in a manner similar to the above-mentioned one, butthe outside diameter may be made smaller not continuously but stepwise.In addition, the whole of the spike 2 may be made as described above.

In the above-mentioned embodiment, since the spike 2 is made solid and agroove having a V-like cross-sectional shape is simply formed in theperipheral surface of the spike 2 to constitute the fluid transferringpassage 28, the strength of the spike 2 can be made large, and there isno risk that the spike 2 is deformed during the expansion, shrink andthe like of the elastic seal 3.

FIG. 7 shows a third embodiment of the invention, and the spike 2 has ajoining portion 40 and a plurality of (in the shown example, two) branchportions 41. The joining portion 40 constitutes the top end portion ofthe spike 2, and the remaining portion of the spike 2 is made of thebranch portions 41. The branch portions 41 are formed integrally withthe joining portion 40 and branch off in downward directions. The fluidtransferring passage 28 is defined between the branch portions 41.

FIG. 8 shows a fourth embodiment of the invention, and the spike 2 ismade of a plurality of divided bodies 43 which extend along the entirelongitudinal length of the spike 2. In this embodiment, the dividedbodies 43 are formed into one pair in axial symmetry, and the fluidtransferring passage 28 is defined between the divided bodies 43.

In the above-mentioned embodiment, since the construction of the spike 2is simple, manufacturing can be easily performed.

FIGS. 9 to 11 show a fifth embodiment of the invention, and the spike 2has a plurality of (in the shown example, two) main portions 45 and abridge portion 46. The main portions 45 are formed to extend along theentire longitudinal length of the spike, while the bridge portion 46 isformed integrally with the main portions 45 and is disposed between themain portions 45 to join these main portions 45 together. The fluidtransferring passage 28 is defined between the main portions 45.

In the above-mentioned embodiment, as the bridge portion 46 is madelarger, the strength of the spike 2 can be made higher and a dead spacecan be made smaller, whereas as the bridge portion 46 is made smaller,the spike 2 can be made smaller in diameter. Namely, it is possible toeasily modify the performance of the spike 2, i.e., the mixing plug, bymodifying the length and the thickness of the bridge portion 46 within arange which does not allow the bridge portion 46 to project outwardlyfrom the spike 2.

FIGS. 12 to 17 show a sixth embodiment of the invention, and as shown inFIGS. 12 and 16, the body 7 generally constitutes the top-portion sideof the housing 1, and the bottom surface of the body 7 is made theabutment surface 16. A plurality of mating projections 48 which projectradially outwardly are circumferentially spaced from one another atequal intervals around the peripheral portion of the bottom portion ofthe body 7. The inside surface of the body 7 except the small-diameterhole 12 in the top portion is made a tapered hole 49 which is taperedupwardly.

The connector 8 generally constitutes the bottom-portion side of thehousing 1. The connector 8 is constructed by integrally forming anexternal tube portion 51 having a tubular shape disposed to extend inthe longitudinal direction, the downstream-side connecting portion 20,and a ring portion 52. The downstream-side connecting portion 20 has atubular shape opened in the longitudinal direction and is disposed toextend through the inside of the external tube portion 51 concentricallyin the longitudinal direction, and the bottom-end portion of thedownstream-side connecting portion 20 projects downwardly from theexternal tube portion 51. A longitudinally middle portion of theexternal tube portion 51 and the top end portion of the downstream-sideconnecting portion 20 are connected together by the ring portion 52having a ring-like shape.

A plurality of mating holes 54 which are formed to extend radiallythrough the external tube portion 51 are circumferentially spaced fromone another at equal intervals around a peripheral portion of theexternal tube portion 51 above the ring portion 52, and the matingprojections 48 of the body 7 are disengageably engaged with the matingholes 54 by elastic deformation, whereby the body 7 and the connector 8are integrated. A portion of the inside surface of the external tubeportion 51 which is adjacent to the ring portion 52 is made theengagement hole 17 in which the flange portion 31 of the spike 2 isfitted. A portion of the inside surface of the external tube portion 51below the ring portion 52 is made the female screw portion 14 in which afemale screw is formed.

The inside of the downstream-side connecting portion 20 is made thecommunication hole 22. In addition, the top surface of thedownstream-side connecting portion 20 and the ring portion 52 is made anabutment surface 47, and this abutment surface 47 and the abutmentsurface 16 of the body 7 are brought into abutment with the flangeportion 31 of the spike 2 to clamp this flange portion 31. Furthermore,a ring projection 56 which projects upwardly is integrally formed on theabutment surface 47, and this ring projection 56 bites the flangeportion 31 of the spike 2 so that the flange portion 31 is more firmlyfixed to the housing 1.

The spike 2 has the straight portion 2A, the tapered portion 2B and aninserting portion 2C which are integrally formed to be arranged in namedorder in the downward direction, as shown in FIGS. 13 to 15 as well.

The straight portion 2A constitutes the top end portion of the spike 2and has an approximately cylindrical solid structure having anapproximately constant outside diameter, and the top end surface of thestraight portion 2A is made an hemispherical surface 58 which isupwardly convex. Accordingly, since the top end surface of the straightportion 2A is made the hemispherical surface 58 which is upwardlyconvex, when the spike 2 comes into abutment with the openable/closableportion 29 of the elastic seal 3 to open the openable/closable portion29, the openable/closable portion 29 is smoothly opened. Since thestraight portion 2A which is the top end portion of the spike is madeapproximately cylindrical, the opening of the openable/closable portion29 smoothly moves downwardly along the straight portion 2A of the spike2 so that the openable/closable portion 29 can be smoothly opened andclosed.

The tapered portion 2B constitutes the spike 2 except the top and bottomend portions and is formed in an (approximately) tapered shape so thatits outside diameter becomes progressively smaller toward the top end.

The inserting portion 2C constitutes the bottom end portion of the spike2, and is made smaller in diameter than the outside diameter of thebottom end of the tapered portion 2B and is made constant in outsidediameter. The inserting portion 2C is inserted into the communicationhole 22 of the connector 8 and is fixed to the inside surface of thecommunication hole 22 by an adhesive or by being fitted thereinto. Sincethe inserting portion 2C of the spike 2 is inserted into and fixed tothe communication hole 22 of the connector 8, the spike 2 can be easilyand firmly fixed to the housing 1.

The tapered portion 2B and the inserting portion 2C are made of at leastthree (in this embodiment, four) fins 27 which project radiallyoutwardly from its axial portion. The fins 27 are circumferentiallyspaced from one another at equal intervals and the longitudinal fluidtransferring passages 28 are defined between adjacent ones of the fins27. Each of the fluid transferring passages 28 is opened radiallyoutwardly and is also opened at both top and bottom ends. The bottom endopening of each of the fluid transferring passages 28 communicates withthe communication hole 22 of the connector 8.

The elastic seal 3 is a modification of the elastic seal of the firstembodiment, and has the openable/closable portion 29, the shrinkableportion 30 and the flange portion 31 which are integrally formed to bearranged in named order in the downward direction.

The shrinkable portion 30 does not have a bellows-like form, unlike theshrinkable portion 30 of the first embodiment. The inside surface of theshrinkable portion 30 is preferably made a smooth surface so that theshrinkable portion 30 can be smoothly fitted onto the spike 2. The topportion of the shrinkable portion 30 is made approximately constant inboth inside and outside diameters, and an inside surface 3A of this topportion has one or a plurality of ring-shaped projections 60 formed tobe arranged in the longitudinal direction as shown in FIG. 13. Thering-shaped projections 60 are formed to project radially inwardly fromthe inside surface of the shrinkable portion 30 and to extend around(approximately) the entire circumference of the inside surface 3A of theshrinkable portion 30. At least one of these ring-shaped projections 60is placed in abutment with the straight portion 2A of the spike 2,whereby the pressure resistance (strength) of the openable/closableportion 29 of the elastic seal 3 can be enhanced to prevent accidentalopening of the openable/closable portion 29.

The shrinkable portion 30 except the top portion is formed in an(approximately) tapered shape so that its inside and outside diametersbecome progressively smaller toward the top end. The outside contours ofthe longitudinal cross-section of the bottom-portion side of theshrinkable portion 30 is made wavy so that the shrinkable portion 30easily expands and shrinks.

Incidentally, it is preferable that an edge which is located on theoutermost side of each of the fins 27 of the tapered portion 2B of thespike 2 be placed in abutment with the inside surface 3A of the elasticseal 3, because it is possible to decrease the volume (or medical-valvevolume or dead space) of the mixing plug in the inside of the elasticseal 3 and it is possible to decrease the amount of backflow of amedicament solution which occurs when the tip 38 of the syringe 37 whichis shown as one example of a male luer is separated from the mixingplug. For this reason, in this embodiment, for example, the insidediameter of the elastic seal 3 is made smaller than the minimum outsidediameter of the fins 27, and the elastic seal 3 is fitted onto the spike2 while it is being elastically deformed, whereby the outside surface ofthe fins 27 of the tapered portion 2B of the spike 2 is brought intoabutment with the inside surface 3A of the elastic seal 3. At this time,a portion of the elastic seal 3, which is brought in abutment with thefins 27, has a cross section of an approximately polygonal shape. Asshown in FIG. 14 by way of example, if the number of the fins 27 of thespike 2 is four, the portion of the elastic seal 3, which is brought inabutment with the fins 27, has a cross section of an approximatelyquadrilateral shape, while as shown in FIG. 17 by way of example, if thenumber of the fins 27 of the spike 2 is three, the portion of theelastic seal 3, which is brought in abutment with the fins 27, has across section of an approximately triangular shape. The outside diameterof each portion of the spike 2 is defined as follows. Namely, thesmallest circuit that passes part of the outermost edge of each portionof each of the fins 27 is assumed, and the diameter of the circle ismade the outside diameter of each portion of the spike 2. Incidentally,the portion of the elastic seal 3, which comes into abutment with thefins 27, may be previously made an approximately polygonal shapecorresponding to the number of the fins 27.

It is to be noted that the housing of the first embodiment and the spikeand the elastic seal of the sixth embodiment may also be combined, orthe spike and the elastic seal of the first embodiment and the housingof the sixth embodiment may also be combined.

In each of the embodiments, when the syringe is extracted from thehousing, the elastic seal expands by the resilient force of the elasticseal, and a metal spring, a resin spring or the like may also be used incombination for the purpose of assisting with this expansion. Inaddition, although in each of the embodiments the invention is appliedto the mixing plug, the invention can be applied to various other kindsof medical valves.

1. A medical valve, to which a male luer is to be separably connected,comprising: (a) a housing having a hollow body opened at the top end,wherein the tip of the male luer is to be removably inserted in thehousing; (b) a longitudinal spike disposed to extend longitudinally inthe housing, the spike except at least the top end portion being formedin a shape approximately tapered upwardly, wherein a fluid transferringpassage is formed to extend longitudinally in the spike, the bottomportion of the fluid transferring passage being connected to a fluidcircuit; and (c) an elastic seal having an elastically deformabletubular shape fitted on the spike to seal the spike, the elastic sealcomprising a top end portion having an openable/closable portion to beopenably closed over the spike, wherein the elastic seal is elasticallydeformed to be downwardly compressed by downward pressure due to the tipof the male luer, thereby the openable/closable portion is brought intoabutment with the spike, and is elastically deformed to be openedradially outwardly to be fitted onto the spike, so that the inside ofthe male luer communicates with the fluid transferring passage of thespike, wherein the spike comprises: (i) a joining portion constitutingthe top end portion of the spike; and (ii) a plurality of longitudinalbranch portions, which constitutes the remaining portion of the spike,formed integrally with the joining portion branching off from thejoining portion, each longitudinal branch portion extending downwardlyfrom the joining portion to the fluid circuit, and wherein the fluidtransferring passage is defined between the branch portions and an innersurface of the elastic seal.
 2. A medical valve, to which a male luer isto be separably connected, comprising: (a) a housing having a hollowbody opened at the top end, wherein the tip of the male luer is to beremovably inserted in the housing; (b) a longitudinal spike disposed toextend longitudinally in the housing, the spike except at least the topend portion being formed in a shape approximately tapered upwardly,wherein a fluid transferring passage is formed to extend longitudinallyin the spike, the bottom portion of the fluid transferring passage beingconnected to a fluid circuit; and (c) an elastic seal having anelastically deformable tubular shape fitted on the spike to seal thespike, the elastic seal comprising a top end portion having anopenable/closable portion to be openably closed over the spike, whereinthe elastic seal is elastically deformed to be downwardly compressed bydownward pressure due to the tip of the male luer, thereby theopenable/closable portion is brought into abutment with the spike, andis elastically deformed to be opened radially outwardly to be fittedonto the spike, so that the inside of the male luer communicates withthe fluid transferring passage of the spike, wherein the longitudinalspike comprises a plurality of longitudinal divided bodies which areformed into one pair in axial symmetry and extend longitudinally alongthe entire length of the spike, and wherein the fluid transferringpassage is defined between the divided portions and an inner surface ofthe elastic seal.
 3. A medical valve, to which a male luer is to beseparably connected, comprising: (a) a housing having a hollow bodyopened at the top end, wherein the tip of the male luer is to beremovably inserted in the housing; (b) a longitudinal spike disposed toextend longitudinally in the housing, the spike except at least the topend portion being formed in a shape approximately tapered upwardly,wherein a fluid transferring passage is formed to extend longitudinallyin the spike, the bottom portion of the fluid transferring passage beingconnected to a fluid circuit; (c) an elastic seal having an elasticallydeformable tubular shape fitted on the spike to seal the spike, theelastic seal comprising a top end portion having an openable/closableportion to be openably closed over the spike, wherein the elastic sealis elastically deformed to be downwardly compressed by downward pressuredue to the tip of the male luer, thereby the openable/closable portionis brought into abutment with the spike, and is elastically deformed tobe opened radially outwardly to be fitted onto the spike, so that theinside of the male luer communicates with the fluid transferring passageof the spike, wherein the spike comprises: (i) two main longitudinalportions extending along the entire longitudinal length of the spike;and (ii) a bridge portion formed integrally with the main portions anddisposed between a segment of the main portions to join the mainportions together, wherein the fluid transferring passage is definedbetween the main portions and an inner surface of the elastic seal.
 4. Amedical valve, to which a male luer is to be separably connected,comprising: (a) a housing having a hollow body opened at the top end,wherein the tip of the male luer is to be removably inserted in thehousing; (b) a longitudinal spike disposed to extend longitudinally inthe housing, the top end portion of the spike having an approximatelycylindrical shape and solid structure, the top end surface of the spikebeing an approximately hemispherical surface which is upwardly convex,the spike, except the top end portion, being formed in an approximatelytapered shape in which the outside diameter becomes progressivelysmaller toward the top end, wherein a fluid transferring passage extendslongitudinally in the outer peripheral surface of the spike, the bottomportion of the fluid transferring passage being connected to a fluidcircuit; (c) an elastic seal having an elastically deformable tubularshape fitted on the spike to seal the spike, the elastic seal comprisinga top end portion having an openable/closable portion to be openablyclosed over the spike, wherein the elastic seal is elastically deformedto be downwardly compressed by downward pressure due to the tip of themale luer, thereby the openable/closable portion is brought intoabutment with the spike, and is elastically deformed to be openedradially outwardly to be fitted onto the spike, so that the inside ofthe male luer communicates with the fluid transferring passage of thespike; and wherein the fluid transferring passage is formed between theouter peripheral surface of the spike and an inner surface of theelastic seal.